A Phase III Clinical Trial to evidence the safety and efficacy of the radio-drug 18f-Fluorocholine (18F-FCH), using PET for the diagnosis of the prostate carcinoma in patients with biochemical relapse.
- Conditions
- Prostate Carcinoma in patients with biochemical relapse.Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2013-004397-99-ES
- Lead Sponsor
- Instituto Tecnológico PET, S.A.U. (ITP)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Male
- Target Recruitment
- 114
1.Male.2.Age=18 years.3. Patients with biochemical relapse of Prostate Carcinoma who have reached any of the following serum PSA levels after a previous primary radical treatment: In patient treated with radical prostatectomy must have passed at least 3 months from the urgery and PSA value will be: (a) higher than 1.0 ng / mL or (b) higher than 0.4 ng / mL in cases of doubling time of less than 6 months. In the patients treated with external radiotherapy or brachytherapy, PSA elevation will be: (c) higher than 2 ng / mL over the nadir. 4. That he has been made an image test (CT with contrast (intravenous and oral), MRI and / or bone scan) up to a maximum of 15 days before the PET-TC with 18F-FCH, or it is scheduled to perform this test in a maximum of 15 days after the PET-TC with 18F-FCH. Contrast CT (intravenous and oral) data are also valid if they are performed with the PET scan with 18F-FCH. 5. Capability to undergo to the explorations. 6. With the signed and dated Informed consent, accepting the participation in the study.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 53
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 54
1.- Surgery performed on the month previous to the PET-CT with 18F-FCH performance. 2. - Prostate biopsy performed on the month before the PET-CT with 18F-FCH test. 3. - Diagnosis of a second primary neoplasia. 4.- Concomitant medication, nutritional supplements or dietetic products containing choline. 5.- Previous known allergic reaction to any of the formulation components of the 18F-FCH or to the contrasts (intravenous or oral) used for the CT. 6.- Life expectancy of less than 6 months. 7.- Lack of cooperation of the patient to participate (following the investigator criteria). 8.- Participation in other clinical trial during the month previous to the inclusion.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method